Label: IMAGE ESSENTIALS OATMEAL MOISTURIZING- dimethicone lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated February 26, 2014

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  • ACTIVE INGREDIENT

    DIMETHICONE 1.25%

    PURPOSE

    SKIN PROTECTANT

  • USES

    TEMPORARILY PROTECTS AND HELPS RELIEVE CHAPPED OR CRACKED SKIN AND HELPS PROTECT FROM THE DRYING EFFECTS OF WIND AND COLD

  • WARNINGS

    FOR EXTERNAL USE ONLY

    WHEN USING THIS PRODUCT

    AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER

    STOP USE AND ASK A DOCTOR IF

    CONDITION WORSENS, OR IF RASH OR IRRITATION DEVELOPS AND LASTS MORE THAN 7 DAYS, OR IF THEY CLEAR UP AND RECUR WITHIN A FEW DAYS

    KEEP OUT OF REACH OF CHILDREN

    IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY (1-800-222-1222)

  • DIRECTIONS

    APPLY AS NEEDED

  • INACTIVE INGREDIENTS

    WATER (AQUA), GLYCERIN, DISTEARYLDIMONIUM CHLORIDE, PETROLATUM, ISOPROPYL PALMITATE, CETYL ALCOHOL, AVENA SATIVA (OAT) KERNEL FLOUR, SODIUM CHLORIDE, DMDM HYDANTOIN, SODIUM HYDROXIDE, BENZYL ALCOHOL, METHYLPARABEN, PROPYLPARABEN

  • LABEL COPY

    IMAGE OF THE LABEL

  • INGREDIENTS AND APPEARANCE
    IMAGE ESSENTIALS  OATMEAL MOISTURIZING
    dimethicone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49738-320
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE12.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    OATMEAL (UNII: 8PI54V663Y)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49738-320-18532 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34702/25/2014
    Labeler - KMART CORPORATION (008965873)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    APOLLO HEALTH AND BEAUTY CARE201901209manufacture(49738-320)
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